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注射用乳剂美国药典标准USP-NF36 729

2016/11/1 7:14:33      点击:

This proposed new general chapter is being previewed here to address the complex methods for analyzing globule size distribution (see the Stimuli article, Examination of Selection of Light-Scattering and Light-Obscuration Acceptance Criteria for Lipid Injectable Emulsions, in this issue of PF). Importantly, the mean droplet size must be submicron in size, while the population of large-diameter fat globules, expressed as the percentage of fat greater than 5 micrometers (i.e., PFAT5), must be kept at a minimum to avoid obstruction of the microvasculature, particularly the capillaries of the lungs. Therefore, these two regions of the globule size distribution (mean droplet size and large-diameter tail) must be controlled within specified limits....


PDF: http://www.genizer.com/upload/file/Globule%20size%20distribution%20in%20lipid%20injectable%20emulsions.pdf